Baxter gets another Class I
This article was originally published in The Gray Sheet
Executive Summary
Baxter's Sept. 28 letter to customers regarding its Meridian hemodialysis instrument has been designated by FDA as a Class I recall, the firm announces Dec. 13. The letter was prompted by reports of broken blood cells related to kinks in the blood tubing sets. Customers were directed to route blood tubing through only one of the channels mounted on the front of the Meridian to reduce the risk of kinks. Three Baxter recalls of Colleague infusion pumps, which FDA seized in October, were designated as Class I earlier in 2005 (1"The Gray Sheet" Oct. 17, 2005, p. 3)...